Angiodynamics Inc – FDA Inspection, Feb 13, 2012

Record Details

This FDA Inspection record concerns Angiodynamics Inc, with an inspection on February 13, 2012, issued by the Center for Devices and Radiological Health, covering devices.

Company: Angiodynamics Inc
Inspection Date: February 13, 2012
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 363e6b69-f616-4c19-956a-b9b30e050d62

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 764802
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.25(b)Training records
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
21 CFR 820.25(b)Training - Lack of or inadequate procedures
21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
21 CFR 820.30(j)Design history file

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Other FDA inspections of Angiodynamics Inc

Date	Classification	Office	Project area
September 26, 2018	Not classified	New England District Office
August 24, 2015	VAI	Center for Devices and Radiological Health	Compliance: Devices
August 24, 2015	VAI	Center for Devices and Radiological Health	Compliance: Devices
May 28, 2014	OAI	Center for Devices and Radiological Health	Compliance: Devices
September 16, 2011	NAI	Center for Devices and Radiological Health	Radiation Control and Health Safety Act